The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Auto-field Ii Ophthalmic Field Scanner.
Device ID | K781462 |
510k Number | K781462 |
Device Name: | AUTO-FIELD II OPHTHALMIC FIELD SCANNER |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-25 |
Decision Date | 1978-09-14 |